| Dioscorea zingiberensis C.H. Wright, also known as ginger, is a unique plant growing in China. The plant is mainly planted in the south part of Shanxi province. Yunxi city of Hubei province. Anhua city of Hunan province and Nanyang city of Henan province. Dioscorea Guanxinning Pian made by extracting the effective parts of the Dioscorea roots, department of State Chinese Medicine of the protected variety has the efficacy on promoting blood circulation and removing blood stasis, nourishing the blood and tranquilization. mainly for heart vascular system diseases. The variety of the original quality standards is simple and not conducive to the production quality control. This issue referred to a large number of basic research on the diosgenin and studied the quality standard of Dioscorea Guanxinning Pian. It's established that increasing leaf shield Determination Guanxinning as a new quality standard for film and studied the product's stability based on the new quality standard.In this subject, we improved the former quality standard of content determination by setting up the high performance liquid chromatography (HPLC) method to control diosgenin as the single component. The method did investigation on many aspects of technology (standard curve, degree of precision, recovery, stability, etc.). At the same time we carried out study on the long-term stability of diosgenin and its capsule according to the technical requirements of the drug stability study. We chose three batches of diosgenin capsule (number 20071012,20071013,20071014) and then placed them under the fixed temperature(T=14～20℃) and relative humidity (RH= 40%～60%). Regularly we took samples from them to inspect different items requested. And then we compared the results with the original. The result certified that the product had good stability. |
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